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InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women

March 26, 2019

BROOKFIELD, Wis.--(BUSINESS WIRE)--Mar 26, 2019--InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence.

This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence.

“It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too,” says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. “All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers.”

Attain provides a guided exercise program to solve incontinence at the source. Muscle stimulation at specific frequencies in an alternating manner increases pelvic floor muscle strength, calming the detrusor muscle, and elicits a full, deep muscle contraction, providing neuromuscular re-training. The lighted biofeedback graph and visual cues guide the user through a series of variable timed, volitional contractions along with a relaxation phase, much like a physical therapy session. A customizable probe inflates to be “comfortably snug,” placing the stimulation in full contact with the vaginal or rectal wall, ensuring a deep muscle contraction with a comfortable, effective stimulation delivery. A probe provides active resistance for a full muscle contraction, repositioning musculature into a resting position between contractions.

“Our medical devices are highly successful in treating stress, urge, and mixed urinary incontinence in women,” says Herschel “Buzz” Peddicord, founder of InControl Medical. “Now after clinical testing, this new revolutionary device is cleared to treat bowel leakage as well. Our goal is to eliminate incontinence as a life factor for as many women as possible.”

InControl Medical , LLC is a pelvic health company focusing on urinary and fecal incontinence. The company’s philosophy is that a first-line treatment should focus on improving the strength and support of the pelvic floor to restore continence naturally. InControl Medical is so confident in the effectiveness of its products, the company offers a Performance, money back Guarantee.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190326005082/en/

CONTACT: Dara Shlifka

646-964-4446

dara@gcomworks.com

KEYWORD: UNITED STATES NORTH AMERICA WISCONSIN

INDUSTRY KEYWORD: SENIORS WOMEN TECHNOLOGY CONSUMER ELECTRONICS HEALTH MEDICAL DEVICES FDA CONSUMER GENERAL HEALTH

SOURCE: InControl Medical, LLC

Copyright Business Wire 2019.

PUB: 03/26/2019 08:03 AM/DISC: 03/26/2019 08:03 AM

http://www.businesswire.com/news/home/20190326005082/en